Coronary Bypass Marker 10-696

GUDID B776106961

Suturing Washer

FIRST CALL, INC.

Metallic coronary bypass marker, non-sterile
Primary Device IDB776106961
NIH Device Record Key3aee9866-a13e-4c4d-b860-8e3fe3868d13
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoronary Bypass Marker
Version Model NumberRev1
Catalog Number10-696
Company DUNS015526185
Company NameFIRST CALL, INC.
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB776106961 [Primary]
HIBCCB7761069619 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MABMarker, Cardiopulmonary Bypass (Vein Marker)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B776106961]

Moist Heat or Steam Sterilization


[B776106961]

Moist Heat or Steam Sterilization


[B776106961]

Moist Heat or Steam Sterilization


[B776106961]

Moist Heat or Steam Sterilization


[B776106961]

Moist Heat or Steam Sterilization


[B776106961]

Moist Heat or Steam Sterilization


[B776106961]

Moist Heat or Steam Sterilization


[B776106961]

Moist Heat or Steam Sterilization


[B776106961]

Moist Heat or Steam Sterilization


[B776106961]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-11
Device Publish Date2019-10-03

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